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FDA NDA

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Pharma & Biotech

Will pediatric KONFIDENT-KID data accelerate KalVista’s sebetralstat approval in hereditary angioedema?

KalVista's sebetralstat pediatric trial data heads to Madrid. What it means for the HAE on-demand market and a 2026 FDA filing. Read the analysis.

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Pharma & Biotech

Why Deciphera Pharmaceuticals’ tirabrutinib NDA matters for the future of CNS lymphoma therapy

FDA accepts tirabrutinib NDA for relapsed or refractory PCNSL. Find out what this means for CNS lymphoma treatment and regulatory strategy.

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Representative image of a knee joint affected by tenosynovial giant cell tumor (TGCT), the rare condition targeted by pimicotinib, now under FDA review for potential approval as a first-in-class oral CSF-1R inhibitor.
Pharma & Biotech

FDA accepts pimicotinib NDA for TGCT: What this signals for rare tumor drug development and the CSF-1R inhibitor class

Find out how Abbisko’s TGCT drug pimicotinib just crossed a major milestone with the FDA—and what this means for patients and the CSF-1R class.

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